FDA will Start Unannounced Inspections in India and China “Soon”
(Thursday, February 10, 2022)
In response to a report from the GAO chastising FDA for its inadequate foreign audit practices particularly in India and China, FDA promised to start unannounced inspections at manufacturing plants in India and China in “early 2022”. FDA also promised to actively hire more inspectors able to travel to India and China by offering higher salary and encouraging bilingual inspectors who don’t need to depend on local untrusted non-FDA translators. The report from the Government Accountability Office (GAO) provides several details on FDA’s inspection practices over the last decade highlighting limitations of FDA’s enforcement in India and China that predate the pandemic. FDA always had to deal with unfilled positions in the two countries of interest, lack of reliable translators and logistical challenges to do unannounced inspections, the gold standard for strict enforcement. The pandemic exacerbated the issues leading to FDA conducting practically no surveillance inspections over the last two years in India and China. Even though FDA promised the GAO late last year about it’s intend to start surprise inspections in India and China, it has not been able to do so due to the omicron wave of the pandemic. It is still early in the year so if FDA was to keep its promise to the GAO, one should expect surprise inspections to begin in the next 1-2 months. However, the likelihood of that is still low. Also, FDA would need strong cooperation from local regulatory agencies. China is notorious for not supporting FDA’s inspections and India, although less restrictive than China, has its own logistical challenges. Either way, we will find out in a few months, if FDA keeps its promise. The manufacturers in China and India should certainly be on the look for an FDA inspector showing up at their doors, unannounced and expect the negative outcomes if not prepared for it.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC